LONDON, UK, 10 December 2007-- SkyePharma PLC (LSE: SKP) today announces that the United States Food and Drug Administration (FDA) has issued an approvable letter for GlaxoSmithKline’s (NYSE:GSK) Requip® XL™ Extended Release tablets. An approvable letter is an official notification from the FDA that contains conditions that must be satisfied prior to obtaining final U.S. marketing approval.
Requip® XL™ is a once-daily oral dopamine agonist developed for the treatment of the signs and symptoms of idiopathic Parkinson’s disease. The new Requip® XL™ formulation uses SkyePharma’s patented GEOMATRIX™ technology and is designed to provide a steady rate of absorption in the body to help reduce daily blood plasma fluctuations. GSK is committed to working with the FDA to address any questions they have and evaluate the best way forward.
Requip® XL™ is approved in eight countries in Europe and a mutual recognition procedure was successfully completed on 27 November 2007, in 17 additional European countries. This step should result in approval of Requip® XL™ and launches in these countries from the first quarter of 2008 onwards.
For further information please contact:
+44 20 7491 1777
Financial Dynamics (UK Enquiries)
+44 20 7831 3113
Trout Group (US Enquiries)
+1 617 583 1308
Using its proprietary drug delivery technologies, SkyePharma develops new formulations of known molecules to provide a clinical advantage and life-cycle extension. The Company has eleven approved products in the areas of oral, inhalation and topical delivery. The Group’s products are marketed throughout the world by leading pharmaceutical companies. For more information, visit www.skyepharma.com
Requip® XL™ was developed and is marketed by GlaxoSmithKline, one of the world’s leading research-based pharmaceutical and healthcare companies. More information on GlaxoSmithKline is available at the company’s website at www.gsk.com.